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IRCT20250525065887N1 IRCT 2025-05-28 Shahid Beheshti University of Medical Sciences Comparison of safety and efficacy of propofol/fentanyl in pediatrics emergency department Comparison of safety and efficacy of propofol/fentanyl and midazolam/fentanyl for procedural sedation 2025-06-22 anticipated 84 Complete https://irct.ir/trial/83788 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method used in this study will be stratified block randomization. Patients will be stratified based on key characteristics such as age, gender, and ASA, and then randomly assigned to study groups using a block size of 4, generated by random allocation software. The random sequence will be created using a random number generator within the software, and the allocation list will be prepared in advance by an independent person not involved in the study implementation or outcome assessment. For allocation concealment, sealed, opaque, and sequentially numbered envelopes will be used. These envelopes will be opened only by the person enrolling the patient, right at the point of assignment, Blinding description: This study will be a single-blind trial. In this context, single-blinding means that the participants (patients and their parents) will not be aware of the specific drug combination administered (either propofol/fentanyl or midazolam/fentanyl). Due to the visible differences between the drugs and the necessity of ensuring medication safety, the administering physician will be aware of the drug type. However, the responsibility for evaluating outcome variables such as pain, distress, depth of sedation, and documentation of adverse events will lie with an independent observer (a trained nurse) who will be blinded to the group allocation. 2 Condition 1: Patients requiring LP. Condition 2: Patients requiring intubation. Condition 3: Patients with limb dislocation or fracture. Intervention 1: Intervention group: In the first intervention group, intravenous fentanyl (1–2 micrograms per kilogram) will be administered first, followed by slow intravenous administration of propofol (1–2 milligrams per kilogram). If the procedure is prolonged or if analgesia or sedation is inadequate, additional doses of fentanyl (1 microgram per kilogram) and propofol (0.5 milligrams per kilogram) will be administered. Intervention 2: Intervention group: In the second intervention group, intravenous midazolam (0.05–0.1 milligrams per kilogram) will be administered first, followed by slow intravenous administration of fentanyl (1–2 micrograms per kilogram). If the procedure is prolonged or if analgesia or sedation is inadequate, additional doses of fentanyl (1 microgram per kilogram) and midazolam (0.05 milligrams per kilogram) will be administered. Yes - There is a plan to make this available What will be shared: All demographic and clinical data collected from patients in the present study will be shared after de-identification. When: Access to the data will begin following the publication of the study results in the form of a scientific article. To whom: The data will be openly accessible to the public. Conditions: Data aggregation for multicenter studies will be possible upon request to the clinical trial coordinator (Dr. Kourosh Soltaniyeh Zanjani) and approval by the research team. Where to obtain: To access the study data, please contact the clinical trial coordinator, Dr. Kourosh Soltaniyeh Zanjani, via email at kouroshsoltaniye@gmail.com. How to obtain: Any requests regarding the research or industrial use of the data will be reviewed by the clinical trial coordinator and the research team and will be answered within seven working days. Comments:
public Kourosh Soltaniyeh Zanjani
Mofid Children's Hospital, Shariati Ave, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1546815514 +98 21 2290 4603 kouroshsoltaniye@gmail.com Shahid Beheshti University of Medical Sciences scientific Kourosh Soltaniyeh Zanjani
Mofid Children's Hospital, Shariati Ave, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1546815514 +98 21 2290 4603 kouroshsoltaniye@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Children aged 3 months to 18 years who are referred to the emergency department of Mofid Children’s Hospital Patients who require procedural sedation 3 months 18 years Both Patients with hemodynamic instability Patients with a history of cardiac diseases Children with known allergies to the study medications Children with allergies to eggs or soy Children classified as ASA physical status class 5 (high anesthesia risk) G97.1 J98.9 T14.3 Other reaction to spinal and lumbar puncture Respiratory disorder, unspecified Dislocation, sprain and strain of unspecified body region Treatment - Drugs Treatment - Drugs Intervention group: In the first intervention group, intravenous fentanyl (1–2 micrograms per kilogram) will be administered first, followed by slow intravenous administration of propofol (1–2 milligrams per kilogram). If the procedure is prolonged or if analgesia or sedation is inadequate, additional doses of fentanyl (1 microgram per kilogram) and propofol (0.5 milligrams per kilogram) will be administered. Intervention group: In the second intervention group, intravenous midazolam (0.05–0.1 milligrams per kilogram) will be administered first, followed by slow intravenous administration of fentanyl (1–2 micrograms per kilogram). If the procedure is prolonged or if analgesia or sedation is inadequate, additional doses of fentanyl (1 microgram per kilogram) and midazolam (0.05 milligrams per kilogram) will be administered. Successful completion of the procedure. Timepoint: After the intervention. Method of measurement: "Success or failure of the procedure (which may include suturing, limb casting, lumbar puncture, intubation, etc.)". Patient recovery time after sedation. Timepoint: After the intervention. Method of measurement: Measurement of the time interval between the administration of the last dose of sedative medication and the point at which the patient is deemed ready for discharge from the emergency department based on post-sedation discharge criteria. Procedural distress. Timepoint: After the intervention. Method of measurement: To assess procedural distress in patients, the Observational Scale of Behavioral Distress (OSBD) will be used by an independent observer (a trained nurse from the emergency department). This scale is utilized to evaluate the level of behavioral distress in children under 18 years of age undergoing medical interventions. Depth of sedation. Timepoint: After the intervention. Method of measurement: The Ramsay Sedation Scale will be used to assess the depth of sedation. Shahid Beheshti University of Medical Sciences Approved 2025-04-29 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd, Velenjac,Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)